Methods and systems for adaptive treatment of disorders in the gastrointestinal tract

ABSTRACT

A system and a method for treatment of a disorder in a gastrointestinal tract of a subject, using a treatment protocol, the treatment protocol being based at least in part on data relating to other subjects and their responses to treatment with various treatment protocols.

RELATED APPLICATIONS

The present application is a continuation in part of PCT PatentApplication No. PCT/IB2017/055565, filed on Sep. 14, 2017, which gainspriority from GB Patent Application No. 1616044.2, filed on Sep. 21,2016, and from Chinese Patent Application No. 2017210463282, filed onAug. 21, 2017, all of which are incorporated by reference as if fullyset forth herein.

FIELD OF THE INVENTION

The present invention relates in general to medical devices andtreatment systems, particularly to methods and systems for adapting atreatment protocol of ingestible capsules introducible to thegastrointestinal (GI) tract of a subject to the subject's response toone or more previous treatment protocols.

SUMMARY OF THE INVENTION

In accordance with an embodiments of the present invention, there isprovided a method for treatment of a disorder in a gastrointestinaltract of a human subject, the method including:

(a) activating a first vibrating ingestible capsule to carry out a firstvibration protocol defined in a first treatment protocol, the firstvibration protocol including delivering vibrations to a wall of the GItract of the subject, thereby to treat the subject;

(b) receiving feedback regarding a response of the subject to treatmentin accordance with the first treatment protocol;

(c) based at least on the feedback, obtaining an updated recommendationfor an updated recommended treatment protocol; and

(d) programming a second programmable vibrating ingestible capsule toimplement a second vibration protocol defined in a second treatmentprotocol, the second treatment protocol being based on the updatedrecommended treatment protocol; and

(e) activating the second programmable vibrating ingestible capsule tocarry out the second vibration protocol, the second vibration protocolincluding delivering vibrations to a wall of the GI tract of thesubject, thereby to treat the subject,

wherein the updated recommendation is electronically obtained based ondata included in a database, the data relating to at least one othersubject.

In some embodiments, the first vibrating ingestible capsule includes aprogrammed capsule, programmed to implement the first vibrationprotocol.

In some embodiments, the first vibrating ingestible capsule includes afirst programmable vibrating ingestible capsule.

In some embodiments, the method further includes, prior to (a):

(f) programming the first programmable vibrating ingestible capsule toimplement the first vibration protocol.

In some embodiments, first vibration protocol includes a defaultvibration protocol. In some embodiments, the first treatment protocolincludes a default treatment protocol.

In some embodiments, the method further includes, prior to (f):

(g) receiving from the subject initial input including subject data;

(h) obtaining an initial recommendation for an initial recommendedtreatment protocol based on at least one characteristic included in thesubject data;

(i) generating the first treatment protocol based on the initialrecommended treatment protocol,

wherein at least one of initial recommendation and the updatedrecommendation is electronically obtained based on data included in thedatabase, the data relating to at least one other subject.

In some embodiments, the subject data includes at least one ofdemographic information, medical information, and treatment history ofthe subject.

In some embodiments, the data included in the database includes, foreach of the at least one other subject, at least one of demographicinformation, medical information, and treatment history information. Insome embodiments, the demographic information includes at least one ofgender, age, date of birth, and geographical location. In someembodiments, the medical information includes at least one ofinformation relating to disorders of the gastrointestinal tract,information relating to chronic diseases, and information relating tomedicines taken regularly. In some embodiments, the treatment historyincludes at least one of information relating to treatment protocolsused, and a response of the at least one other subject to treatment withthe treatment protocols.

In some embodiments, obtaining the initial recommendation includes:

selecting the at least one characteristic of the subject from thereceived subject data;

identifying in the database a treatment protocol used for treatment ofother subjects sharing the at least one characteristic with the subject;and

recommending the treatment protocol as the initial recommended treatmentprotocol.

In some embodiments, selecting the at least one characteristic includesselecting at least two characteristics of the subject, and wherein theidentifying includes identifying in the database a treatment protocolused for treatment of other subjects sharing each of the at least twocharacteristics with the subject.

In some embodiments, identifying includes identifying in the database atreatment protocol successfully used for treatment of the othersubjects.

In some embodiments, the method further includes, following (h) andprior to (i):

providing the initial recommended treatment protocol to a decisionmaker; and

obtaining from the decision maker an indication whether or not the firsttreatment protocol should be identical to the initial recommendedtreatment protocol.

In some embodiments, the method further includes, if the indicationobtained from the decision maker indicates that the first treatmentprotocol should not be identical to the initial recommended treatmentprotocol;

obtaining from the decision maker at least one change to be made to theinitial recommended treatment protocol; and

applying the at least one change to the initial recommended treatmentprotocol thereby to obtain the first treatment protocol.

In some embodiments, the decision maker is a medical practitioner.

In some embodiments, the decision maker includes an electronic decisionmaker. In some embodiments, the at least one change obtained from theelectronic decision maker is within predetermined limits forelectronically changing the initial recommended treatment protocol. Insome embodiments, the predetermined limits are defined in the subjectdata.

In some embodiments, programming the first programmable vibratingingestible capsule includes:

providing the first vibration protocol to a capsule control unit,functionally associated with the first programmable vibrating ingestiblecapsule; and

the capsule control unit programming the first programmable vibratingingestible capsule to implement the first vibration protocol.

In some embodiments, programming includes remotely transmitting thefirst vibration protocol to the first programmable vibrating ingestiblecapsule. In some embodiments, remotely transmitting includestransmitting the first vibration protocol using a short range wirelesscommunication method. In some embodiments, remotely transmitting thefirst vibration protocol includes transmitting to the first programmablevibrating ingestible capsule a list of vibration parameters foreffecting the first vibration protocol. In some embodiments, remotelytransmitting the first vibration protocol includes transmitting to thefirst programmable vibrating ingestible capsule executable code foreffecting the first vibration protocol.

In some embodiments, activating the first vibrating ingestible capsuleincludes activating a timer of the first vibrating ingestible capsule toimmediately begin effecting the first vibration protocol. In someembodiments, activating the first vibrating ingestible capsule includesactivating the first vibrating ingestible capsule to identify ingestionof the first vibrating ingestible capsule by the subject, and to begineffecting the first vibration protocol immediately followingidentification of ingestion of the first vibrating ingestible capsule.

In some embodiments, receiving feedback includes receiving from thesubject feedback indicating times at which the subject experienced bowelmovements during or following the treatment in accordance with the firsttreatment protocol. In some embodiments, receiving feedback includesreceiving from the subject feedback indicating a physical feelingexperienced by the subject during or following the treatment inaccordance with the first treatment protocol. In some embodiments,receiving feedback includes receiving from the subject feedbackindicating at least one characteristic of fecal matter excreted by thesubject during or following the treatment in accordance with the firsttreatment protocol.

In some embodiments, receiving feedback includes receiving, from atleast one sensor, information regarding expelling of the first vibratingingestible capsule from the body of the subject. In some embodiments,the information regarding expelling includes a time at which the firstvibrating ingestible capsule was expelled from the body of the subject.In some embodiments, the information regarding expelling includes anidentification of the first vibrating ingestible capsule. In someembodiments, the identification includes at least one of anidentification number, an RFID, a barcode, and specific dimensions ofthe first vibrating ingestible capsule.

In some embodiments, receiving feedback further includes receiving fromthe at least one sensor information regarding at least onecharacteristic of fecal matter excreted from the body of the subject.

In some embodiments, the at least one sensor includes a toilet-bowlmounted sensor, and wherein the receiving the information from thesensor includes:

at the toilet-bowl mounted sensor, identifying at least one of the firstvibrating ingestible capsule and fecal matter being expelled from thebody of the subject;

at the toilet bowl sensor, gathering the information regarding expellingof the first vibrating ingestible capsule or of expelled fecal matter;and

transmitting the information from the toilet-bowl mounted sensor.

In some embodiments, receiving feedback includes receiving feedback fromat least one of a medical practitioner or a care-giver of the subjectregarding the response of the subject to treatment in accordance withthe first treatment protocol.

In some embodiments, receiving feedback includes:

-   -   receiving from the subject feedback indicating at least one of        times at which the subject experienced bowel movements and        characteristics of fecal matter expelled during or following the        treatment in accordance with the first treatment protocol; and    -   receiving, from at least one sensor, information indicating at        least one of a time at which the first vibrating ingestible        capsule was expelled from the body of the subject and        characteristics of fecal matter expelled from the body of the        subject; and

obtaining the updated recommendation includes:

-   -   comparing the feedback received from the subject to the        information received from the at least one sensor;    -   assigning a reliability weight to the feedback received from the        subject based on the comparison; and    -   taking the reliability weight of the feedback received by the        user into consideration when using the feedback to obtain the        updated recommendation.

In some embodiments, obtaining the updated recommendation includes:

selecting the at least one characteristic of the subject from at leastone of the received subject data and the received feedback;

identifying in the database a treatment protocol used for treatment ofother subjects sharing the at least one characteristic with the subject;and

recommending the treatment protocol as the updated recommended treatmentprotocol.

In some embodiments, selecting the at least one characteristic includesselecting from the received feedback at least one other characteristicrelating to the response of the subject to the treatment with the firstvibrating ingestible capsule, and wherein the identifying includesidentifying in the database a treatment protocol used for treatment ofother subjects who had a similar response to the treatment in accordancewith the first treatment protocol.

In some embodiments, identifying includes identifying in the database atreatment protocol successfully used for treatment of the othersubjects.

In some embodiments, the method further includes, following (c) andprior to (d):

providing the updated recommended treatment protocol to a decisionmaker; and

obtaining from the decision maker an indication whether or not thesecond treatment protocol should be identical to the updated recommendedtreatment protocol.

In some embodiments, the method further includes, if the indicationobtained from the decision maker indicates that the second treatmentprotocol should not be identical to the updated recommended treatmentprotocol:

obtaining from the decision maker at least one change to be made to theupdated recommended treatment protocol; and

applying the at least one change to the updated recommended treatmentprotocol thereby to obtain the second treatment protocol.

In some embodiments, the decision maker is a medical practitioner. Insome embodiments, the decision maker includes an electronic decisionmaker.

In some embodiments, programming the second programmable vibratingingestible capsule includes:

providing the second vibration protocol to a capsule control unit,functionally associated with the second programmable vibratingingestible capsule; and

the capsule control unit programming the second programmable vibratingingestible capsule to implement the second vibration protocol.

In some embodiments, programming the second programmable vibratingingestible capsule includes remotely transmitting the second vibrationprotocol to the second programmable vibrating ingestible capsule. Insome embodiments, remotely transmitting includes transmitting the secondvibration protocol using a short range wireless communication method. Insome embodiments, remotely transmitting the second vibration protocolincludes transmitting to the second programmable vibrating ingestiblecapsule a list of vibration parameters for effecting the secondvibration protocol. In some embodiments, remotely transmitting thesecond vibration protocol includes transmitting to the secondprogrammable vibrating ingestible capsule executable code for effectingthe second vibration protocol.

In some embodiments, activating the second programmable vibratingingestible capsule includes activating a timer of the secondprogrammable vibrating ingestible capsule to immediately begin effectingthe second vibration protocol. In some embodiments, activating thesecond programmable vibrating ingestible capsule includes activating thesecond programmable vibrating ingestible capsule to identify ingestionof the second programmable vibrating ingestible capsule by the subject,and to begin effecting the second vibration protocol immediatelyfollowing identification of ingestion of the second programmablevibrating ingestible capsule.

In some embodiments, the method further includes, following (c), usingthe received feedback together with subject data received from thesubject to update the database to reflect the response of the subject tothe treatment in accordance with the first treatment protocol.

In some embodiments, the method further includes, following (e),repeating steps (b)-(e).

In accordance with an embodiments of the present invention, there isprovided a system for treatment of a disorder in a gastrointestinaltract of a human subject, the system including:

at least one input module adapted to receive input from a human,typically at least one of the subject, a medical practitioner treatingthe subject, and a care giver of the subject;

a computer readable memory adapted to store, or storing, a subjectprofile for the subject, the subject profile including subject datareceived as initial input by the at least one input module;

a database including data relating to subjects treated for disorders inthe gastrointestinal tract and to treatment protocols used for thesubjects;

a first vibrating ingestible capsule adapted to be activated toimplement a first vibration protocol defined in a first treatmentprotocol, and adapted, in an operative mode, to deliver vibrations to awall of the GI tract of the subject in accordance with the firstvibration protocol, thereby to treat the subject;

a second programmable vibrating ingestible capsule adapted to beprogrammed and activated to implement a second vibration protocoldefined in a second treatment protocol, and adapted, in an operativemode, to deliver vibrations to a wall of the GI tract of the subject inaccordance with said second vibration protocol, thereby to treat thesubject;

a processor, functionally associated with the at least one input module,the computer readable memory, and the database;

wherein the at least one input module is adapted to receive feedbackregarding a response of the subject to treatment in accordance with thefirst treatment protocol,

wherein the processor is configured, based at least on the feedback, to:

-   -   automatically obtain an updated recommendation for an updated        recommended treatment protocol based on at least one of said        feedback, data included in said subject profile, and data        included in said database, said data included in said database        relating to at least one other subject of said subjects; and    -   effect programming of the second programmable vibrating        ingestible capsule to implement the second vibration protocol,        the second treatment protocol including the second vibration        protocol being based on the updated recommended treatment        protocol.

In some embodiments, the first vibrating ingestible capsule includes aprogrammed capsule, programmed to implement the first vibrationprotocol.

In some embodiments, the first vibrating ingestible capsule includes afirst programmable vibrating ingestible capsule.

In some embodiments, the processor is further configured to effectprogramming of the first programmable vibrating ingestible capsule toimplement the first vibration protocol.

In some embodiments, the first vibration protocol includes a defaultvibration protocol. In some embodiments, the first treatment protocolincludes a default treatment protocol.

In some embodiments, the processor is further configured, prior toeffecting programming of the first programmable vibrating ingestiblecapsule, to:

-   -   obtain an initial recommendation for an initial recommended        treatment protocol based on at least one characteristic included        in the subject data; and    -   generate the first treatment protocol based on the initial        recommended treatment protocol,

wherein the processor electronically obtains at least one of initialrecommendation and the updated recommendation based on data included inthe database, the data relating to at least one other subject of thesubjects.

In some embodiments, the subject data includes at least one ofdemographic information, medical information, and treatment historyinformation of the subject. In some embodiments, the data included inthe database includes, for each of the at least one other subject, atleast one of demographic information, medical information, and treatmenthistory information. In some embodiments, the demographic informationincludes at least one of gender, age, date of birth, and geographicallocation. In some embodiments, the medical information includes at leastone of information relating to disorders of the gastrointestinal tract,information relating to chronic diseases, and information relating tomedicines taken regularly. In some embodiments, the treatment historyinformation includes at least one of information relating to treatmentprotocols used, and a response of the at least one other subject totreatment with the treatment protocols.

In some embodiments, the processor is configured to obtain the initialrecommendation by:

selecting the at least one characteristic of the subject from thesubject data;

identifying in the database a treatment protocol used for treatment ofother subjects sharing the at least one characteristic with the subject;and

recommending the treatment protocol as the initial recommended treatmentprotocol.

In some embodiments, the processor is further configured to provide theinitial recommended treatment protocol to a decision maker and toreceive from the decision maker an indication whether or not the firsttreatment protocol should be identical to the initial recommendedtreatment protocol.

In some embodiments, the processor is further configured, if theindication received from the decision maker indicates that the firsttreatment protocol should not be identical to the initial recommendedtreatment protocol, to receive from the decision maker at least onechange to be made to the initial recommended treatment protocol and toapply the at least one change to the initial recommended treatmentprotocol thereby to generate the first treatment protocol.

In some embodiments, the decision maker is a medical practitioner.

In some embodiments, the decision maker includes an electronic decisionmaker. In some embodiments, at least one change received from theelectronic decision maker is within predetermined limits forelectronically changing the initial recommended treatment protocol. Insome embodiments, the predetermined limits are defined in the subjectdata.

In some embodiments, the system further includes a capsule control unitfunctionally associated with the processor and with the at least onesecond programmable vibrating ingestible capsule, the capsule controlunit adapted to receive from the processor the second vibration protocoland to program the second programmable vibrating ingestible capsule toimplement the second vibration protocol.

In some embodiments, the capsule control unit includes a communicationmodule for remotely transmitting the second vibration protocol to thesecond programmable vibrating ingestible capsule. In some embodiments,the capsule control unit is adapted to remotely transmit the secondvibration protocol using a short range wireless communication method. Insome embodiments, the capsule control unit is adapted to remotelytransmit to the second programmable vibrating ingestible capsule a listof vibration parameters for effecting the second vibration protocol. Insome embodiments, the capsule control unit is adapted to remotelytransmit to the second programmable vibrating ingestible capsuleexecutable code for effecting the second vibration protocol.

In some embodiments, the first vibrating ingestible capsule includes afirst programmable vibrating ingestible capsule, and wherein the capsulecontrol unit is adapted to receive from the processor the firstvibration protocol and to program the first programmable vibratingingestible capsule to implement the first vibration protocol.

In some embodiments, the capsule control unit includes a communicationmodule for remotely transmitting the first vibration protocol to thefirst programmable vibrating ingestible capsule. In some embodiments,the capsule control unit is adapted to remotely transmit the firstvibration protocol using a short range wireless communication method. Insome embodiments, the capsule control unit is adapted to remotelytransmit to the first programmable vibrating ingestible capsule a listof vibration parameters for effecting the first vibration protocol. Insome embodiments, the capsule control unit is adapted to remotelytransmit to the first programmable vibrating ingestible capsuleexecutable code for effecting the first vibration protocol.

In some embodiments, the feedback includes feedback received from thesubject indicating times at which the subject experienced bowelmovements during or following the treatment in accordance with the firsttreatment protocol. In some embodiments, the feedback includes feedbackreceived from the subject indicating a physical feeling experienced bythe subject during or following the treatment in accordance with thefirst treatment protocol. In some embodiments, the feedback includesfeedback received from the subject indicating at least onecharacteristic of fecal matter excreted by the subject during orfollowing the treatment in accordance with the first treatment protocol.

In some embodiments, the system further includes at least one sensoradapted to provide to the processor information regarding expelling ofthe first vibrating ingestible capsule from the body of the subject. Insome embodiments, the information regarding expelling includes a time atwhich the first vibrating ingestible capsule was expelled from the bodyof the subject. In some embodiments, the information regarding expellingincludes an identification of the first vibrating ingestible capsule. Insome embodiments, the identification includes at least one of anidentification number, an RFID, a barcode, and specific dimensions ofthe first vibrating ingestible capsule.

In some embodiments, the at least one sensor is further adapted toprovide to the processor information regarding at least onecharacteristic of excrement excreted from the body of the subject.

In some embodiments, the sensor provides the information to theprocessor as the feedback.

In some embodiments, the at least one sensor includes a toilet-bowlmounted sensor. In some embodiments, the toilet-bowl mounted sensorincludes:

a receptacle adapted to be mounted within a toilet bowl and to receiveexcrement therein, the receptacle including:

-   -   a first side wall, a second side wall, a third side wall, and a        fourth side walls, the first and fourth side walls being        generally opposite one another, the second and third side walls        being generally opposite one another, and the third side wall        including a side wall ingress; and    -   a floor surface attached to the first, second, third, and fourth        side walls, the floor surface including a wire frame or a mesh        including openings suitable for removal of excrement from the        receptacle;

a pushing mechanism, movable relative to the receptacle and adapted topush content of the receptacle, the pushing mechanism including amovable ingress;

a capsule measuring and/or identification mechanism, adapted to at leastone of measure dimensions of an ingestible capsule included in theexcrement and uniquely identify the ingestible capsule;

a capsule releasing mechanism for releasing the ingestible capsule fromthe receptacle; and

a controller for controlling operation of the pushing mechanism, thecapsule releasing mechanism, and the capsule measuring and/oridentification mechanism,

wherein the capsule measuring and/or identification mechanism includes ahollow formed between the side wall ingress and the movable ingress whenthe pushing mechanism is adjacent the third side wall, the hollow beingsuitable for enclosing the capsule.

In some embodiments, motion of the pushing mechanism is adapted to applyforce to the excrement in the receptacle thereby to break-down theexcrement to be suitably sized for removal via the openings. In someembodiments, the pushing mechanism is adapted to sense at least onecharacteristic of the excrement based on an amount of the force appliedto the excrement in order to break down the excrement.

In some embodiments, the hollow formed between the movable ingress andthe side wall ingress has a predetermined cross section, thepredetermined cross section being suitably sized to match at least oneof a cross section and a diameter of a specific type of capsule expectedto be expelled into the receptacle.

In some embodiments, the capsule measuring and/or identificationmechanism includes at least one first sensor mounted on the third sidewall and adapted to sense engagement between a surface of the pushingmechanism and the third side wall.

In some embodiments, the capsule measuring and/or identificationmechanism includes at least one second sensor mounted onto the side wallingress, and adapted to sense engagement between an exterior surface ofa capsule and a surface of the side wall ingress.

In some embodiments, the capsule measuring and/or identificationmechanism includes a weighing mechanism adapted to sense a weight of acapsule captured in the hollow.

In some embodiments, the capsule measuring and/or identificationmechanism further includes a capsule identification system, adapted touniquely identify a capsule captured in the hollow.

In some embodiments, the controller is adapted to receive input from thecapsule measuring and/or identification mechanism relating to theingestible capsule following capturing thereof in the hollow, and toprovide information based on the input to the processor. In someembodiments, the controller is adapted to receive input from the pushingmechanism relating to at least one characteristic of the excrement, andto provide information based on the input to the processor.

In some embodiments, the feedback includes feedback received from atleast one of a medical practitioner or a care-giver of the subjectregarding the response of the subject to the treatment in accordancewith the first treatment protocol.

In some embodiments, the processor is further configured to use thesubject data and the received feedback to update the database to reflectthe response of the subject to the treatment in accordance with thefirst treatment protocol.

In accordance with an embodiments of the present invention, there isprovided a toilet-bowl mounted sensor, including:

a receptacle adapted to be mounted within a toilet bowl and to receiveexcrement therein, the receptacle including:

-   -   a first side wall, a second side wall, a third side wall, and a        fourth side walls, the first and fourth side walls being        generally opposite one another, the second and third side walls        being generally opposite one another, and the third side wall        including a side wall ingress; and    -   a floor surface attached to the first, second, third, and fourth        side walls, the floor surface including a wire frame or a mesh        including openings suitable for removal of excrement from the        receptacle;

a pushing mechanism, movable relative to the receptacle and adapted topush content of the receptacle, the pushing mechanism including amovable ingress;

a capsule measuring and/or identification mechanism, adapted to at leastone of measure dimensions of an ingestible capsule included in theexcrement and uniquely identify the ingestible capsule;

a capsule releasing mechanism for releasing the ingestible capsule fromthe receptacle; and

a controller for controlling operation of the pushing mechanism, thecapsule releasing mechanism, and the capsule measuring and/oridentification mechanism,

wherein the capsule measuring and/or identification mechanism includes ahollow formed between the side wall ingress and the movable ingress whenthe pushing mechanism is adjacent the third side wall, the hollow beingsuitable for enclosing the ingestible capsule.

In some embodiments, the sensor further includes a sealcircumferentially arranged about the receptacle, wherein the receptacleand the seal are sized to circumferentially engage and seal against thetoilet bowl along an entire cross section thereof, such that all matterexpelled into the toilet bowl is received in the receptacle.

In some embodiments, at least one of the first, second, third, andfourth side walls includes a plurality of water jets, functionallyassociated with a conduit, the water jets adapted to receive water fromthe conduit and to spray the water into the receptacle for washing outexcrement therefrom.

In some embodiments, the openings in the floor surface are suitablysized so that the ingestible capsule cannot pass through the openings.

In some embodiments, the floor surface is angled from the second sidewall toward the third side wall, such that gravity assists in directingthe ingestible capsule toward the capsule measuring and/oridentification mechanism.

In some embodiments, the pushing mechanism extends generally parallel tothe second side wall, and is movable between the second and third sidewalls. In some embodiments, motion of the pushing mechanism is adaptedto apply force to the excrement in the receptacle thereby to break-downthe excrement to be suitably sized for removal via the openings.

In some embodiments, during the motion, the pushing mechanism is adaptedto sense at least one characteristic of the excrement based on andamount of the force applied to the excrement in order to break down theexcrement.

In some embodiments, the pushing mechanism includes a plurality of wireframe elements connected to one another by a connector surface.

In some embodiments, the hollow formed between the movable ingress andthe side wall ingress has a hollow cross section, the cross sectionbeing suitably sized to match at least one of a cross section and adiameter of a specific type of ingestible capsule expected to beexpelled into the receptacle.

In some embodiments, the capsule measuring and/or identificationmechanism includes at least one first sensor mounted on the third sidewall and adapted to sense engagement between a surface of the pushingmechanism and the third side wall. In some embodiments, the capsulemeasuring and/or identification mechanism further includes at least onesecond sensor mounted onto the side wall ingress, and adapted to senseengagement between an exterior surface of an ingestible capsule capturedin the hollow and a surface of the side wall ingress.

In some embodiments, the capsule measuring and/or identificationmechanism including a weighing mechanism adapted to sense a weight of aningestible capsule captured in the hollow. In some embodiments, theweighing mechanism forms part of, or is mounted on, the capsulereleasing mechanism.

In some embodiments, the capsule measuring and/or identificationmechanism includes a capsule identification system, adapted to uniquelyidentify an ingestible capsule captured in the hollow. In someembodiments, the capsule identification system includes a barcode readeradapted to read a barcode printed on an exterior surface of theingestible capsule captured in the hollow, thereby to uniquely identifythe ingestible capsule. In some embodiments, the capsule identificationsystem includes a QR-code reader adapted to read a QR-code printed on anexterior surface of the ingestible capsule captured in the hollow,thereby to uniquely identify the ingestible capsule. In someembodiments, the capsule identification system includes a textinterpretation mechanism adapted to capture and interpret anidentification number or text printed on an exterior surface of theingestible capsule captured in the hollow, thereby to uniquely identifythe ingestible capsule. In some embodiments, the capsule identificationsystem includes an image processing mechanism adapted to capture andinterpret an image printed on an exterior surface of the ingestiblecapsule captured in the hollow, thereby to uniquely identify theingestible capsule. In some embodiments, the capsule identificationsystem includes an RFID tag reader adapted to read an RFID tag mountedonto the ingestible capsule captured in the hollow, thereby to uniquelyidentify the ingestible capsule.

In some embodiments, the capsule releasing mechanism includes a hingedportal formed in the floor surface beneath the side wall ingress, suchthat opening of the portal releases the ingestible capsule from thehollow and from the receptacle. In some embodiments, opening and closingof the portal is controlled by the controller.

In some embodiments, the controller is adapted to receive input from thecapsule measuring and/or identification mechanism relating to theingestible capsule following capturing thereof, and to provide capsuleinformation based on the input to a remote location. In someembodiments, the controller is adapted to receive input from the pushingmechanism relating to at least one characteristic of the excrement, andto provide excrement information based on the input to a remotelocation.

In some embodiments, the controller is adapted to provide at least oneof the capsule information and the excrement information by wiredcommunication with the remote location, via a communication wireextending from the controller along the toilet bowl. In someembodiments, the controller is adapted to provide at least one of thecapsule information and the excrement information by wirelesscommunication with the remote location.

In some embodiments, the capsule information provided to the remotelocation includes at least one of a time at which the ingestible capsulewas expelled into the receptacle or captured in the hollow, dimensionsof the ingestible capsule, a weight of the ingestible capsule, and anidentification of the ingestible capsule.

In some embodiments, the controller is adapted to provide power to thepushing mechanism, the capsule measuring and/or identificationmechanism, and the capsule releasing mechanism. In some embodiments, thecontroller is adapted to receive power from a power supply wireextending along the toilet bowl.

In accordance with an embodiments of the present invention, there isprovided a method for measuring and identifying an ingestible capsuleexpelled into a toilet bowl, the method including:

mounting a sensor as described herein in the toilet bowl, such thatmatter expelled into the toilet bowl, including the ingestible capsule,is received in the receptacle;

breaking down excrement included in the matter so that excrement issized to be removed from the receptacle via the openings in the floorsurface;

pushing the ingestible capsule toward the third side wall therebycapturing the ingestible capsule in the hollow; and

measuring whether at least one of a cross section of the ingestiblecapsule matches an expected cross section and a diameter of theingestible capsule matches an expected diameter.

In some embodiments, breaking down includes moving the pushing mechanismback and forth between the second and third side walls, thereby to breakdown the excrement.

In some embodiments, measuring includes weighing the ingestible capsule.In some embodiments, the method further includes, following thecapturing, uniquely identifying the capsule.

In some embodiments, the method further includes reporting at least oneof measurements of the ingestible capsule, a weight of the ingestiblecapsule, and an identity of the ingestible capsule to a remote location.

In some embodiments, reporting is only carried out if the cross sectionof the ingestible capsule matches the expected cross section or if thediameter of the ingestible capsule matches the expected diameter. Insome embodiments, reporting is only carried out if a weight of theingestible capsule matches an expected weight.

In some embodiments, the method further includes, following themeasuring, releasing the ingestible capsule from the receptacle via thecapsule releasing mechanism.

BRIEF DESCRIPTION OF THE FIGURES

The foregoing discussion will be understood more readily from thefollowing detailed description of the invention, when taken inconjunction with the accompanying FIGS. (1-12), in which:

FIG. 1 is a schematic block diagram of a system for treatment of adisorder in the gastrointestinal tract of a subject according to anembodiment of the present invention;

FIGS. 2A and 2B together are a schematic flowchart of a method fortreatment of a disorder in the gastrointestinal tract of a subjectaccording to the present invention, the method utilizing the inventivesystem of FIG. 1;

FIGS. 3A, 3B, and 3C are, respectively, a partially cut away side planview, a partially cut away perspective view, and a top plan view of aninventive toilet-bowl mounted sensor for capturing and identifying aningestible capsule according to the present invention, the toilet-bowlmounted sensor forming part of the system of FIG. 1;

FIG. 4 is a sectional view of another embodiment of a receptacle,forming part of an inventive toilet-bowl mounted sensor according to thepresent invention, in a stand-by mode;

FIGS. 5A and 5B are, respectively, a perspective view and a sectionalview of the receptacle of FIG. 4 in an operational mode;

FIG. 6 is a partial sectional view of the receptacle of FIG. 4 in acapsule capturing mode;

FIG. 7 is a sectional view of the receptacle of FIG. 4 in a capsulereleasing mode; and

FIG. 8 is a schematic flowchart of a method for capturing andidentifying an ingestible capsule that has been expelled into a toiletbowl according to the present invention, the method utilizing theinventive toilet-bowl mounted sensor of any one of FIGS. 3A-7.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The principles of the inventive system and method for treatment of adisorder in the gastrointestinal tract of a subject, and the inventivetoilet-bowl mounted sensor for capturing and identifying an ingestiblecapsule that has been expelled into a toilet-bowl and method of usethereof, may be better understood with reference to the drawings and theaccompanying description.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not limited in its applicationto the details of construction and the arrangement of the components setforth in the following description or illustrated in the drawings. Theinvention is capable of other embodiments or of being practiced orcarried out in various ways. Also, it is to be understood that thephraseology and terminology employed herein is for the purpose ofdescription and should not be regarded as limiting.

For the purposes of this application, the term “subject” relates to ahuman subject.

For the purposes of this application, the term “vibrating ingestiblecapsule” relates to an ingestible capsule adapted to at leastintermittently vibrate, for a cumulative duration of at least oneminute, in accordance with a vibration protocol of the capsule, suchthat, when the capsule is disposed in the gastrointestinal (GI) tract ofa subject and is in operative mode, the vibrations are delivered to awall of the GI tract of the subject, so as to provide mechanicalstimulation to the GI tract of the subject. Typically, such mechanicalstimulation is provided so as to treat GI disorders such asconstipation, diarrhea, gastroparesis, obesity, and the like.

For the purposes of this application, the term “programmable vibratingingestible capsule” relates to a vibrating ingestible capsule adapted tovibrate in accordance with vibration protocol, the vibration protocoladapted to be programmed into the capsule by a capsule control unit.Specifically, the vibration protocol of a programmable vibratingingestible capsule may be changed by re-programming the capsule toimplement a different vibration protocol.

For the purposes of this application, the term “programmed vibratingingestible capsule” relates to a vibrating ingestible capsule adapted tovibrate in accordance with a vibration protocol, the vibration protocolbeing programmed into the capsule, for example by the manufacturerthereof. The programmed vibration protocol is fixed, and the capsulecannot be re-programmed.

For the purposes of this application, the term “capsule control unit”relates to a device adapted to produce a vibrating ingestible capsuleand/or to activate a vibrating ingestible capsule. Typically, thecapsule control unit is adapted to receive a vibration protocol, and totransmit the vibration protocol to a vibrating ingestible capsule,thereby to program the capsule to implement the vibration protocol. Forexample, the capsule control unit may provide the vibration protocol toa processor of the programmable vibrating ingestible capsule by means ofremote communication, such as by short range wireless communication, andmay provide the protocol as a list of parameters, as executable code, orin any other manner suitable for the capsule to implement the vibrationprotocol. For activation, the capsule control unit typically is adaptedto transmit an activation signal to a vibrating ingestible capsule,indicating to a processor of the capsule that the vibration protocolshould be initiated. In some cases, the capsule control unit is alsoadapted to receive a signal from the capsule, indicating that theprogrammed vibration protocol and/or the activation instruction havebeen received.

For the purposes of this application, the term “short range wirelesscommunication method” relates to any wireless communication method orprotocol in which signals are communicated up to a maximum range of atmost 1 kilometer, at most 500 meters, at most 300 meters, at most 200meters, at most 100 meters, at most 50 meters, or at most 10 meters suchas, for example, Bluetooth communication, Wi-Fi communication, RFIDsignal communication, low frequency magnetic field, and the like.

For the purposes of this application, the term “intermittently activatedvibration engine” refers to a vibration engine which is adapted tovibrate at certain times and not to vibrate at other times, theactivation times being selected by a processor or other control unitcontrolling the vibration engine, such as a processor of a vibratingingestible capsule of which the vibration engine forms part.

For the purposes of this application, the term “vibration protocol”relates to a protocol specifying vibration parameters of anintermittently activated vibration engine of a vibrating ingestiblecapsule. Typically, the vibration protocol relates to a vibration rate(number of vibration cycles per hour) which is typically in the range of1-300 cycles per hour, a vibration period and a repose period for eachvibration cycle, a vibration frequency which is typically in the rangeof 1-500 Hz, an amount of force to be exerted by the vibrations, a setof vibration and non-vibration durations (i.e. a set specifying that thecapsule vibrates at the vibration rate for a certain duration or acertain number of cycles, then rests for a certain duration, vibratesagain for a certain duration or number of cycles, and so forth), and thelike. In some cases, the vibration protocol may also relate to anactivation delay for initiating vibration (a duration between activationof the capsule and the first activation of the vibration engine) whichis typically in the range of 0-24 hours. The vibration and non-vibrationdurations may be defined as absolute times, or may be relative toingestion or activation of the capsule. For example, a treatmentprotocol may indicate that the activation delay is 4 hours (i.e.intermittently activated vibration engine should begin vibration 4 hoursafter activation or ingestion of the capsule), and that following theactivation delay the capsule should vibrate at a frequency of 150 Hz andat a duty cycle of 60%, for a duration of 2 hours, stop vibrating for 2hours, and subsequently resume vibration for a duration of four hours,at a frequency of 250 Hz and at a duty cycle of 85%, each cycle having avibration period of 3 seconds and a repose period of 26 seconds. Asanother example, the activation delay is 8 hours, and subsequentlyvibration begins at 200 Hz at a 40% duty cycle in repetitive cycleshaving a 1 second vibration period followed by a 27 second reposeperiod. After each five cycles of vibration, the vibration frequency isincreased by 2 Hz, and the duty cycle is increased by 1%.

For the purposes of this application, the term “treatment procedure”relates to parameters of a treatment using vibrating ingestiblecapsules, which are typically defined by a treating physician or medicalpractitioner. For example, the treatment procedure may include thenumber of capsule to be taken in a specific time duration (e.g. 3capsules per week, 2 capsules per day, etc.), the frequency at whichcapsules should be taken, the time of day at which capsules should betaken, whether the capsule should be taken with or without food, and thelike.

For the purpose of this application, the term “treatment protocol”relates to all aspects of treatment of a subject with a vibratingingestible capsule, and includes the treatment procedure as well as thevibration protocol to be used for treating the subject.

For the purposes of this application, the term “default treatmentprotocol” relates to a standard treatment protocol which is typicallyused when initially treating a subject with a vibrating ingestiblecapsule, or when insufficient information is available for tailoring aspecific treatment protocol to the subject.

For the purposes of this application, the terms “default vibrationprotocol” relates to a standard vibration protocol which is typicallyused when initially treating a subject with a vibrating ingestiblecapsule, or when insufficient information is available for tailoring aspecific vibration protocol to the subject. In some cases, the defaultvibration protocol is the vibration protocol used by programmedvibrating ingestible capsules.

For the purposes of this application, the term “electronicallyobtained”, when relating to a treatment protocol, relates to a treatmentprotocol which was generated by or determined by a machine based onelectronic information, such as information included in a computerizedor electronic profile of a subject and/or data included in a database,without direct human input or intervention.

For the purposes of this application, the term “successful treatment”,and variations thereof, relates to treatment of a subject with one ormore capsules implementing a specific treatment protocol such thatduring or following the treatment, the symptoms of the subject areimproved by a significant degree, as defined by medical practices. Fortreatment of chronic constipation, successful treatment is treatmentthat results in an increase of at least one bowel movement pertwo-weeks, an increase of at least one bowel movement per week, anincrease of three bowel movements per two-weeks, or an increase of atleast two bowel movements per week, on average.

For the purposes of this application, the term “decision maker” relatesto any entity capable of applying logic to a proposed treatmentprotocol, in order to determine whether or not the proposed treatmentprotocol is suitable for treatment of a subject, and/or whether theproposed treatment protocol must be modified in order to be suitable fortreatment of the subject. The decision maker may be a human, or amachine including suitable artificial intelligence or logic components.

For the purposes of this application, the term “electronic decisionmaker” relates to a decision maker which is fully based on artificialintelligence or logic, and which makes decisions regarding thesuitability of a proposed treatment protocol for treatment of a subjectwithout direct input from a human, only based on artificial logic and/orintelligence. The electronic decision maker is typically limited todecisions within a scope determined by a human, such as a medicalpractitioner, prior to use of the electronic decision maker. Forexample, a doctor may define a range of vibration protocols which isacceptable for use for a subject, and the electronic decision maker maymake decisions within that range, but would refer to a human decisionmaker if decisions are required that are outside of the predefinedrange.

Referring now to the drawings, FIG. 1 is a schematic block diagram of asystem 100 for treatment of a disorder in the gastrointestinal tract ofa subject according to an embodiment of the present invention.

As seen in FIG. 1, system 100 includes at least one input module 102operative to receive input from at least one of the subject, a medicalpractitioner or medical personnel treating the subject, and a care giverof the subject, such as a parent, guardian, or personal medical aide,for example via a user interface 104. The input module 102 may furtherbe operative to receive input from one or more sensors, as described infurther detail hereinbelow. In some embodiments, separate input modules102 and/or different user interfaces 104 are used for different inputproviders.

The input module 102 may be any suitable input module, and may include,for example, a receiver or transceiver configured to receive the inputas a communication signal from a remote location, such as from the oneor more sensors, or a keyboard or touchpad configured to receive inputentered directly thereinto, for example by the subject, a caretaker ofthe subject, medical personnel treating the subject, or any other inputprovider.

A computer readable memory stores a subject profile 106 for the subject,including subject data. The subject profile 106 may be functionallyassociated with the input module 102, and the subject data may beprovided to the subject profile 106 as input, via one of more inputmodule 102. For example, the subject, the medical practitioner ormedical personnel treating the subject, or the care giver of the subjectmay provide the subject data, for example as an initial input.

In some embodiments, the subject data includes demographic informationof the subject, such as the subject's name, identification number suchas a social security number or passport number, address, date of birth,age, gender, contact information, and emergency contact information.

In some embodiments, the subject data includes medical information ofthe subject, such as the subject's medical history and particularly themedical history of constipation, diarrhea, gastroparesis, obesity,and/or gastrointestinal diseases, medications and/or treatmentspreviously tried by the subject, particularly for constipation,diarrhea, gastroparesis, obesity, and/or gastrointestinal diseases,results of medical examination such as etiology of constipation, resultsfrom physical examination such as digital rectal examinations, resultsfrom gastrointestinal explorations such as transit or motility studies,anorectal manometry, balloon test expulsion, scintigraphy scan, or othergastrointestinal explorations, blood test information, stool sampleinformation, microbiome information, information relating to allergies,chronic diseases, medications currently being used, and the like. Insome embodiments, the medical information may be collected before,during, and/or after treatment in accordance with the method describedherein.

In some embodiments, the subject data may also include informationrelating to the subject's lifestyle, such as diet, water intake, andphysical activity.

In some embodiments, for female subjects, the subject data may alsoinclude obstetric medical history.

In some embodiments, the subject data may include guidelines fortreatment of the subject, or a “treatment safe zone” or “self adaptingzone” for the subject, such as, for example, a range of vibrationprotocols suitable for safe treatment of the subject, which may be usedby an electronic decision maker as described in further detailhereinbelow.

In some embodiments, the system includes a database 108, which may befunctionally associated with one or more input module 102 and/or withsubject profile 106. Database 108 includes data relating to subjectstreated for disorders in the gastrointestinal tract. In someembodiments, data is input into the database 108 directly by an inputprovider, such as one or more subjects, a medical practitioner, medicalpersonnel, a researcher or administrator at a research facility, and thelike, for example via input module 102 and user interface 104. In someembodiments, the data is input into the database 108 automatically, forexample directly from the subject profile 106, as described in furtherdetail hereinbelow.

In some embodiments, data included in database 108 relates to at leastone other subject, and preferably to a plurality of subjects other thanthe subject.

In some embodiments, the data included in database 108 includes, foreach other subject, demographic information such as gender, age, date ofbirth, and the like, as well as information relating to disorders of thegastrointestinal tract experienced by the other subject, to treatmentsprovided for such disorders, and to the other subject's response to suchtreatments. In some embodiments, the data included in database 108 maybe substantially parallel to the subject data. Specifically, in someembodiments, the data included in the database lists, for each of theother subjects, one or more vibration protocols, treatment procedures,and/or treatment protocols used to treat the other subject, and theother subject's response to treatment with such protocols andprocedures.

A processor 110 is functionally associated with subject profile 106 andwith database 108, and may further be functionally associated with inputmodule 102. Processor 110 is functionally associated with a computerreadable storage medium 112 storing instructions, which may be carriedout by the processor 110, as explained in further detail hereinbelowwith respect to FIGS. 2A and 2B.

In some embodiments, processor 110 is configured to receive, for examplevia input module 102 or via subject profile 106, feedback relating to aresponse of the subject to treatment with a specific treatment protocol,a specific vibration protocol, or specific treatment procedures. Forexample, the feedback may indicate times at which the subjectexperienced bowel movements following the treatment, a physical feelingexperienced by the subject during or immediately after the treatment, orone or more characteristics of fecal matter excreted by the subjectduring or following the treatment.

In some embodiments, the feedback is received from a human, such as fromthe subject, a medical practitioner or medical professional treating thesubject, or a care-giver of the subject. In some embodiments, thefeedback is received from a sensor, as described in further detailhereinbelow.

In some embodiments, the processor 110 is further configured to assign aweight, or a reliability score, to such feedback, as described infurther detail hereinbelow.

In some embodiments, processor 110 is configured to electronicallyobtain an initial recommendation for an initial recommended treatmentprotocol for the subject. In some embodiments, the initialrecommendation may be a default initial recommendation. In someembodiments, the initial recommendation may be based on at least oneselected characteristic included in the subject data. In someembodiments, the initial recommendation may be based on data included inthe database 108, for example data relating to other subjects sharingthe selected characteristic(s) with the subject.

In some embodiments, processor 110 is configured to electronicallyobtain an updated recommendation for an updated recommended treatmentprotocol for the subject, based on received feedback relating to aresponse of the subject to a previously used treatment protocol, on atleast one characteristic included in the subject data and/or on dataincluded in the database 108, for example data relating to othersubjects sharing the characteristic with the subject or sharing theexperienced response with the subject.

The updated recommendation may change one or more parameters of thevibration protocol or of the treatment protocol, relative to a previousrecommendation. For example, the updated recommendation may change thevibration frequency, the delay time until starting the vibrationprotocol, the duty cycle, the segment in the GI tract in which thecapsule is intended to vibrate, the length of the vibration time in eachvibration cycle, the rest time of each vibration cycle, and/or thevibration intensity.

The system 100 further includes a first vibrating ingestible capsule 114a, adapted to implement a first vibration protocol for deliveringvibrations, or mechanical stimulation, to a wall of the GI tract of thesubject thereby to treat the gastrointestinal disorder of the subject,the first vibration protocol forming part of a first treatment protocolfor the subject. The system further includes at least one secondprogrammable vibrating ingestible capsule 114 b, adapted to beprogrammed to implement a second vibration protocol deliveringvibrations, or mechanical stimulation, to a wall of the GI tract of thesubject thereby to treat the gastrointestinal disorder of the subject,the second vibration protocol forming part of a second treatmentprotocol for the subject. As explained in further detail hereinbelow, insome embodiments, the first and/or second vibration protocols and/ortreatment protocols may be identical to, or may be based on, recommendedvibration protocols and/or treatment protocols electronically obtainedby processor 110.

Each of capsules 114 a and 114 b may include a sensor module includingone or more sensors; a timer; an intermittently activated vibrationengine; a processor, functionally associated with the sensor(s) in thesensor module, with the timer, and with the vibration engine; a receiveror transceiver functionally associated with the processor; and at leastone power source providing power to the sensor module, the timer, thevibration engine, the processor, and/or the receiver/transceiver.

In some embodiments, the sensors included in the sensor module may senseconditions in the vicinity of the capsule. As such, the sensors mayinclude: a pH sensor adapted to sense the pH in the vicinity of thecapsule; a light sensor adapted to sense a degree of illumination in thevicinity of the capsule; a pressure sensor adapted to sense pressureapplied to the capsule; and/or an orientation sensor, such as anaccelerometer, adapted to sense the three dimensional orientation of thecapsule.

The power source of capsules 114 a and 114 b may be any suitable powersource, such as, for example, one or more alkaline or silver oxidebatteries, lithium batteries, primary batteries, rechargeable batteries,capacitors and/or super capacitors.

In some embodiments, the capsules 114 a and 114 b may be substantiallyas described in U.S. Patent Application Publication No. 2015/0073315 andin U.S. Pat. No. 9,078,799 which are incorporated by reference as iffully set forth herein.

In some embodiments, first vibrating ingestible capsule 114 a may be aprogrammed vibrating ingestible capsule, programmed, for example at atime of manufacturing thereof, to implement a specific vibrationprotocol as the first vibration protocol. In other embodiments, thefirst vibrating ingestible capsule 114 a is a first programmablevibrating ingestible capsule 114 a, adapted to be programmed toimplement the first vibration protocol.

In some embodiments, the first treatment protocol may be a defaulttreatment protocol, used as the standard initial treatment protocol forsubjects suffering from any disorder, or from a specific disorder, ofthe gastrointestinal tract, and may define a default vibration protocolas the first vibration protocol.

A capsule control unit 116, functionally associated with processor 110and with at least one programmable vibrating ingestible capsule, isadapted to receive a vibration protocol and to program a programmablevibrating ingestible capsule to implement the received vibrationprotocol. In some embodiments, the capsule control unit 116 is adaptedto receive a treatment protocol including treatment procedures and avibration protocol and to program the programmable vibrating ingestiblecapsule to implement the received vibration protocol.

In some embodiments, capsule control unit 116 may include a dedicatedprocessor; a programming module; a verification and activation module;and/or a transceiver or other communication module. The capsule controlunit may further include at least one power source providing power tocomponents of the capsule control unit.

In some embodiments, the capsule control unit 116 further includes auser interface, adapted to provide output to the subject or to anotheruser associated with the subject, such as a medical practitioner or caregiver. In some such embodiments, the capsule control unit 116 may promptthe subject, via the user interface, to ingest one or more capsules inaccordance with the treatment protocol received by the capsule controlunit.

Capsule control unit 116 may be any suitable control unit, including asuitably programmed computing device such as a smartphone, a tabletcomputer, laptop computer, desktop computer, and the like, or may be adedicated control unit, e.g. a stand-alone control unit or a controlunit forming part of another medical device.

In system 100, capsule control unit 116, or a dedicated processorthereof, is adapted to receive from processor 110 the second treatmentprotocol, for example via a transceiver of the capsule control unit 116,and to program the second programmable vibrating ingestible capsule 114b to implement the second vibration protocol defined in the secondtreatment protocol. In some embodiments, in which first vibratingingestible capsule 114 a is programmable, capsule control unit 116 maybe further adapted to similarly receive the first treatment protocol,from processor 110 or from another source, and to program the firstvibrating ingestible capsule 114 a to implement the first vibrationprotocol defined in the first treatment protocol.

In some embodiments, the programming module of capsule control unit 116is configured to receive the second vibration protocol from theprocessor of the capsule control unit, and to program a processor ofsecond programmable vibrating ingestible capsule 114 b to implement thesecond vibration protocol upon activation thereof or upon ingestion ofthe second vibrating ingestible capsule. Similarly, in embodiments inwhich first vibrating ingestible capsule 114 a is programmable, theprogramming module of capsule control unit 116 is configured to receivethe first vibration protocol from the processor of the capsule controlunit, and to program a processor of first vibrating ingestible capsule114 a to implement the first vibration protocol upon activation thereofor upon ingestion of the first vibrating ingestible capsule.

In some embodiments, the programming module of capsule control unit 116may include a transmitter, or may be functionally associated with atransmitter, for transmission of the first and/or second vibrationprotocol to a receiver/transceiver of capsules 114 a and/or 114 b, forexample using a short range wireless communication method.

In some embodiments, the programming module of capsule control unit 116transmits the vibration protocol to the capsule 114 a or 114 b as asequence of parameter signals, such as digits, indicating time framesfrom activation or from ingestion and vibration parameters to be used atthose time frames. In some embodiments, the programming module ofcapsule control unit 116 transmits the vibration protocol to the capsule114 a or 114 b as executable code to be used by the processor of thecapsule to automatically activate the vibration engine thereof inaccordance with the vibration protocol.

In some embodiments, a memory element within the capsule 114 a or 114 bincludes multiple vibration protocols which may be effected by thecapsule, and the programming module of capsule control unit 116transmits to the capsule an indication of a specific one of the multiplevibration protocols to be used, such as a vibration protocol identifier.

In some embodiments, the activation module of the capsule control unit116 is configured to activate the first and/or second programmablevibrating ingestible capsule for operation.

In some cases, the activation includes activating the capsule toidentify ingestion thereof by the subject, and subsequently to beginimplementation of the vibration protocol programmed therein. In otherembodiments, activation of the capsule includes immediate activation ofthe timer to start counting time till activation of the vibrationengine. Such embodiments assume that the capsule is activated shortlybefore the subject ingests the capsule. In yet other embodiments,activation of the capsule occurs following ingestion of the capsule bythe subject, by providing to the ingested capsule a remote activationsignal.

In some embodiments, the activation module of capsule control module 116includes a transmitter, or is functionally associated with a transmitteror transceiver, and activates the capsule by providing an activationsignal thereto.

In some embodiments, the activation module also includes a verificationmodule, configured to verify that the capsule received the vibrationprotocol transmitted thereto and is capable of effecting the vibrationprotocol without error. In some embodiments, the verification moduleincludes, or is functionally associated with a receiver, receiving fromthe capsule a verification signal indicating that the capsule hasreceived the vibration protocol. In some embodiments, the verificationmodule includes a vibration sensor, sensing the capsule vibrating inaccordance with a specific vibration pattern indicative of verificationthereof.

In some embodiments, the processor 110 and the capsule control unit 116are functionally associated with a decision maker 118, which is adaptedto receive, for example from processor 110, a suggestion orrecommendation for a treatment protocol or a vibration protocol, and toapprove, reject, or modify the suggested or recommended protocol fortreatment of the subject.

In some embodiments, the decision maker may be a human decision maker,such as a medical practitioner or treating gastroenterologist, who mayreceive the suggested or recommended treatment protocol or vibrationprotocol by the protocol being presented on a display visible to thehuman decision maker, or by receiving an electronic message, such as anemail message, specifying the recommended or suggested treatmentprotocol or vibration protocol.

The human decision maker may approve, reject, or modify the receivedrecommended treatment protocol or vibration protocol by interacting witha user interface 104 of one of input modules 102, or by interactingdirectly with capsule control unit 116, for example with an input moduleor user interface thereof.

In other embodiments, the decision maker 118 is an electronic decisionmaker, such as a suitably equipped computer or server, which is adaptedto electronically receive the suggested or recommended treatmentprotocol or vibration protocol, and to approve, reject, or modify thesuggested or recommended treatment protocol or vibration protocol. Insome embodiments, the logic applied by the electronic decision maker maybe learned over time, for example based on the results that similartreatment had for other subjects. In some embodiments, the electronicdecision maker may include an artificial intelligence component.

In some embodiments, decisions made by an electronic decision maker arelimited to be within certain limitations, or within a “self adaptingzone” predefined by a human decision maker, such as safety regulationsdefined by a manufacturer of the capsule and/or medical limitationsdefined by a medical practitioner. For example, the manufacturer mayindicate that the frequency of vibrations has an upper limit of 1000 Hz,in which case the decision maker will not permit, or approve, anyprotocol requiring vibration at a frequency greater than 1000 Hz. Asanother example, a medical practitioner may indicate that no changes canbe made to treatment procedures, in which case the electronic decisionmaker would make decisions relating to the vibration protocol, but woulddefer any decisions relating to the treatment procedures to a humandecision maker, for example via an electronic message.

In some embodiments, the limitations are based on the structure and/orfunctionality of the capsule, such as safety limitations defined by themanufacturer. In such embodiments, the same limitations apply tomultiple subjects, and multiple capsules. In some embodiments, thelimitations are defined by the medical practitioner based on the medicalstate of the subject, and are specific to the subject being treated.Such limitations may be provided as input by the medical practitioner,for example as part of the subject data stored in the subject profile.

In some embodiments, the electronic decision maker may be functionallyassociated with the capsule control unit 116, and may transmit theapproved or modified treatment protocol or vibration protocol directlyto the capsule control unit 116. In other embodiments, the electronicdecision maker provides the approved or modified treatment protocol orvibration protocol to processor 110, which may transmit the treatmentprotocol to capsule control unit 116 as described hereinabove.

In some embodiments, processor 110 and/or subject profile 106 arefurther associated with at least one sensor 120, which is adapted tosense, and provide to processor 110 and/or to subject profile 106,information regarding a vibrating ingestible capsule being expelled fromthe body of the subject. In some embodiments, the sensor comprises atoilet-bowl mounted sensor. The toilet bowl mounted sensor may be anysuitable sensor, such as any one of the inventive sensors describedhereinbelow with reference to FIGS. 3A to 8, or a toilet-bowl mountedsensor known in the art, for example as described in US PatentApplication Publication No. 2009/0326514, which is hereby incorporatedby reference.

The information provided by sensor 120 may include a time at which thevibrating ingestible capsule was expelled from the body of the subject,an identification of the expelled capsule, and/or information regardingcharacteristics of excrement expelled from the body of the subject.

Reference is now additionally made to FIGS. 2A and 2B, which, together,are a schematic flowchart of a method for treatment of a disorder in thegastrointestinal tract of a subject according to the present invention,the method utilizing the inventive system of FIG. 1.

As seen, and as described in further detail hereinbelow, the method maystart at step 200, at step 218, or at step 222.

In some embodiments, the method begins at step 200, by obtaining initialinput including subject data for a subject to be treated using themethod. The subject data typically includes demographic informationand/or medical history information for the subject, required forinitiating subject profile 106. In some embodiments, the input mayadditionally include information relating to other subjects, such asinformation required for creating or updating database 108. In someembodiments, the input may further include limitations defining a “selfadapting zone” for an electronic decision maker, as describedhereinabove.

As mentioned hereinabove with reference to FIG. 1, the input may bereceived from the subject, from a medical facility or medicalpractitioner treating the subject, or from a caretaker of the subject.In some embodiments, the input is provided to input module 102 via auser interface 104 which is local to system 100, while in otherembodiments the input may be provided via a remote user interface 104,and communicated to input module 102 or to processor 110 using asuitable communication method.

At step 202, a subject profile, such as subject profile 106 describedhereinabove with respect to FIG. 1, is generated for the subject, forexample by processor 110, based on the input relating to the subject.

Turning to step 204, it is seen that a recommendation for a recommendedtreatment protocol for the subject is obtained. In some embodiments, therecommendation is electronically obtained by processor 110. In someembodiments, the recommendation is based on information included in thesubject profile 106.

For example, in an initial treatment round, the subject profile mayindicate that the motility in the subject's digestive system is slowerthan the motility of the average digestive system, such that the foodreaches the colon after a longer time than the average 10 hours. In suchembodiments, processor 110 may recommend a treatment protocol having along enough activation delay time so as to ensure that the capsulevibrates when it has reached the subject's large intestine, and does notvibrate prematurely.

In some embodiments the recommendation may also be based on dataobtained from database 108, the data relating to one or more othersubjects. For example, in an initial treatment round, the subjectprofile 106 may indicate that the subject is a female aged 55. Processor110 may access database 108 to identify treatment protocols and/orvibration protocols that were successfully used to treat other femaleshaving similar ages, for example aged 50-60. One such identifiedprotocol may be suggested as the recommended treatment protocol for thesubject, or a new treatment protocol, including characteristics of anumber of such identified protocols, may be generated as the recommendedtreatment protocol for the subject.

As described in further detail hereinbelow, the method described hereinis iterative, and subject profile 106 may be updated to reflect theresponse of the subject to treatment with a specific treatment protocol.As such, in subsequent treatment rounds, processor 110 may use datarelating to such responses when generating the recommendation for thenext treatment protocol to be used.

Returning to the example provided above, the subject profile 106 may, ina later treatment round, indicate that the subject's condition did notimprove when treated with a vibration protocol providing capsulevibration at a frequency of 150 Hz. The processor may then recommend anupdated vibration protocol having a different vibration frequency.

Selection of a subsequent treatment protocol may also be based on datafrom the database, relating to at least one other user. In the exampleabove in which the subject's condition did not improve when treated witha vibration protocol providing capsule vibration at a frequency of 150Hz, the processor may, when identifying in database 108 potentialtreatment protocols, limit the identified protocols to ones providingvibration at a higher frequency, provided that the higher frequency iswithin a predetermined permissible range for the capsule and/or for thespecific subject, such as up to 250 Hz. As another alternative, theprocessor may identify treatment protocols that were successfully usedto treat females aged 50-60 which did not respond well to treatment withcapsule vibration at a frequency of 150 Hz.

When updating the vibration protocol or treatment protocol in a secondor subsequent treatment round, the updated recommended treatmentprotocol may change one or more parameters of the vibration protocol orof the treatment protocol, relative to a previous recommendation. Forexample, the updated recommendation may change parameters of thevibration protocol, such as the vibration frequency, the delay timeuntil starting the vibration protocol, the duty cycle, the segment inthe GI tract in which the capsule is intended to vibrate, the length ofthe vibration time in each vibration cycle, the rest time of eachvibration cycle, and/or vibration intensity, and/or parameters of thetreatment procedures, such as the frequency at which a capsule should beingested, the time of day at which the capsule should be ingested,and/or whether the capsule should ingested with or without food.

As seen at step 206, the processor 110 may then check whether or not theobtained recommended treatment protocol is significantly different froma previously used treatment protocol. Naturally, in an initial iterationof the method described herein, step 206 would be obviated. In someembodiments, a treatment protocol would be considered ‘significantlydifferent’ from another treatment protocol if the vibration protocoland/or the treatment procedures defined by the treatment protocol, orany portion thereof, is not in the range of allowed treatment protocolsand/or characteristics defined for the subject, as describedhereinabove.

If the recommended treatment protocol is significantly different fromthe treatment protocol used in a previous round of treatment, at step208 the recommended treatment protocol is provided by processor 110 todecision maker 118, which may be a human decision maker, such as amedical practitioner treating the subject, or may be an electronicdecision maker, as described hereinabove.

As seen at step 210, input from the decision maker is received byprocessor 110. The decision maker may require that the recommendedtreatment protocol be modified prior to treating the subject, or mayindicate that the recommended treatment protocol, or a similar treatmentprotocol based on the recommended treatment protocol, should not be usedfor the subject, and such requirements may be provided as the input. Inembodiments in which the decision maker is human, the input may beprovided via user interface 104 and input module 102.

At step 212, processor 110 checks whether or not the decision maker hasapproved treating the subject using a treatment protocol which is basedon the recommended treatment protocol. If processor 110 identifies thatthe decision maker has not approved use of a treatment protocol based onthe recommended protocol, the method returns to step 204 for selectionof another recommended treatment protocol.

Otherwise, if processor 110 identifies that the decision maker approveduse of the recommended treatment protocol, at step 214 the processorchecks whether or not the decision maker has required making any changesto the recommended treatment protocol in order to obtain the treatmentprotocol to be used.

As seen at step 216, if such changes are required, processor 110 appliesthe changes to the recommended treatment protocol, thereby to generatethe treatment protocol to be used. Once the treatment protocol isgenerated at step 216, the generated treatment protocol, or, in someembodiments, only the vibration protocol defined thereby, is provided byprocessor 110 to capsule control unit 116 at step 218.

Alternately, if no changes were required to the recommended treatmentprotocol (at step 214), or if the recommended treatment protocol is notsignificantly different from the treatment protocol used in animmediately previous round of treatment (at step 208), the treatmentprotocol to be used is set to be identical to the recommended treatmentprotocol, and the treatment protocol, or only the vibration protocoldefined thereby, is provided by processor 110 to capsule control unit116, at step 218.

As another alternative, the method may start from step 218, for exampleby providing to the capsule control unit 116 a default treatmentprotocol or a default vibration protocol to be used in a first treatmentiteration. In such embodiments, the default treatment protocol or thedefault vibration protocol may be provided by the manufacturer of thecapsule or by a medical practitioner for any subject beginning treatmentusing the system of FIG. 1, regardless of the subject's profile or ofany data collected in the database regarding other subjects. In otherembodiments, the method may begin with steps 200 and 202 so as to createthe subject profile, and may then proceed directly to step 218 whereinthe default treatment protocol or default vibration protocol is providedto the capsule control unit 116.

Once the capsule control unit 116 has received the vibration protocol tobe used, possibly as part of the treatment protocol to be used, at step220 the capsule control unit 116 programs a programmable vibratingingestible capsule, such as capsule 114 a or 114 b, to implement thevibration protocol upon activation of the capsule or upon ingestionthereof, substantially as described hereinabove with respect to FIG. 1.In some embodiments, the capsule control unit 116 also provides outputto the subject or to a caretaker thereof, for example via a display orother user interface, the output indicating the treatment proceduresdefined in the treatment protocol to be used.

As seen at step 222, once the programmable vibrating ingestible capsule(e.g. 114 a or 114 b) has been programmed to implement the vibrationprotocol, the capsule is activated, for example by the activation moduleof capsule control unit 116 as described hereinabove, and is provided tothe subject for ingestion thereof, thereby to treat the subject. Asexplained hereinabove, the subject or a caretaker thereof is notified ofthe treatment procedures, and is instructed to ingest the programmedcapsule in accordance with the treatment procedures defined in thetreatment protocol being used.

In some embodiments, the capsule may be provided to the subject foringestion without previous activation thereof. In such embodiments, thecapsule may be activated while it is within the gastrointestinal tractof the subject, for example by providing a remote signal, from theexterior of the subject's body to a receiver of the capsule.

In some embodiments, the first vibrating ingestible capsule used toeffect the first iteration of treatment is not a programmable capsule,but rather a programmed capsule, programmed to implement a specificvibration protocol, such as the default vibration protocol, for exampleas described hereinabove with reference to capsule 114 a of FIG. 1. Insome such embodiments, the method may begin at step 222, by activationof the programmed capsule and treatment of the subject therewith. Inother embodiments, the method may begin with steps 200 and 202 so as tocreate the subject profile, and may then proceed directly to step 222wherein the programmed capsule is activated and used to treat thesubject.

During treatment of the subject, or following such treatment, processor110 receives feedback from a user, which may be the subject, a medicalpractitioner treating the subject, and/or a caretaker of the subject,regarding the subject's response to the treatment, as seen at step 224.In some embodiments, the feedback is provided to processor 110 via userinterface 104 and input module 102.

In some embodiments, the feedback may indicate times at which thesubject experienced bowel movements during or following treatment inaccordance with a specific treatment protocol, or a number ofspontaneous bowel movements (SBM) or complete spontaneous bowelmovements (CSBM) experienced during or following the treatment.

In some embodiments, the feedback may indicate a physical feelingexperienced by the subject during or following treatment in accordancewith a specific treatment protocol, such as a feeling of completeevacuation following a bowel movement, straining, bloating, gas,flatulence, pain during bowel movements, pain at times other than duringa bowel movement, or other adverse events occurring during or followingthe treatment. For example, the subject may provide feedback indicatingthat vibration was felt when the capsule was passing through the rectalarea of the subject, or that stomach pains were relieved following thetreatment.

In some embodiments, the feedback may indicate treatment procedures usedby the subject during implementation of the treatment protocol, such as,for example, a time of day at which a vibrating ingestible capsule wasingested.

In some embodiments, the feedback may indicate at least onecharacteristic of fecal matter excreted by the subject during orfollowing the treatment in accordance with the treatment protocol. Forexample, the subject may provide feedback indicating the Bristol stoolmeasure of a bowel movement following the treatment.

At step 226, the processor 110 may receive feedback from one or moresensors 120. In some embodiments, a sensor 120 is mounted in thetoilet-bowl, and provides information regarding expelling of thevibrating ingestible capsule from the body of the subject. In someembodiments, the information includes an indication of a time at whichthe vibrating ingestible capsule was expelled from the body of thesubject. In some embodiments, the information includes an identificationof the expelled capsule. In some embodiments, the information includesinformation regarding fecal matter expelled by the subject, such as forexample a Bristol stool measure of the fecal matter, as describedhereinbelow.

As discussed hereinabove with respect to FIG. 1, a toilet-bowl mountedsensor 120 may be any suitable sensor known in the art, such as thatdescribed in US Patent Application Publication No. 2009/0326514, or maybe an inventive sensor as described hereinbelow with reference to FIGS.3A to 7. An exemplary method by which the inventive sensors of FIGS. 3Ato 7 obtain and provide feedback to processor 110 is describedhereinbelow with respect to FIG. 8.

In some embodiments, at step 228 processor 110 may optionally compare,or cross-reference, the feedback provided by the user at step 224 to thefeedback received from the sensor at step 226, and may assign areliability weight to the feedback from the user and/or from the sensorbased on the results of such comparison, as seen at step 230.

For example, the processor 110 may compare the times at which thesubject reported to have had bowel movements, and the time at which thesensor reported that the capsule was expelled. If the subject did notreport a bowel movement at the time that the capsule was expelled, thisis indicative of the subject not providing accurate feedback, and assuch the sensor based feedback would be assigned a higher reliabilityweight than the feedback received from the subject.

At step 232, the processor 110 updates the subject profile 106 based onthe feedback provided by the subject, the medical practitioner, and/orthe caretaker at step 224, and/or based on the feedback provided by thesensor 120 at step 226. In embodiments in which the subject and/orsensor feedback is assigned a reliability weight at step 230, thereliability weight is taken into consideration when updating the subjectprofile, such that a greater significance is given to the more reliablefeedback.

Subsequently, the method returns to step 204, and an updated treatmentprotocol recommendation for the subject is obtained based on the updateduser profile and based on data from database 108, which data relates toat least one other subject.

In some embodiments, following updating of the subject profile 106 atstep 232, the processor 110 creates or updates an entry in database 108relating to the subject, for example based on the update subject profile106, as seen at step 234.

Reference is now made to FIGS. 3A, 3B, and 3C which are, respectively, apartially cut away side plan view, a partially cut away perspectiveview, and a top plan view of an inventive toilet-bowl mounted sensor 300for capturing and identifying an ingestible capsule according to thepresent invention. In some embodiments, the toilet-bowl mounted sensor300 may form part of the system of FIG. 1, for example as sensor 120.

As seen in FIGS. 3A-3C, sensor 300 includes a receptacle 302 surroundedat a top end thereof by a sealing rim 304. The sensor 300 is adapted tobe placed within a toilet bowl 306, at a portion thereof in whichsealing rim 304 engages, and seals against, the entire circumference ofthe toilet bowl, such that any excrement expelled into the toilet bowlwould be caught in receptacle 302.

In some embodiments, the receptacle 302 is formed of a wire frame or amesh frame, having gaps or openings large enough to allow water andexcrement to pass through, but smaller than the diameter of the capsuleto be caught in the receptacle, such that the capsule does not fallthrough the frame.

Extending along toilet bowl 306, from the exterior thereof to acontroller 308 of sensor 300 (described in further detail hereinbelow),is at least one conduit 310 for providing water flow to sensor 300, andat least one wire 312 for providing electrical power to sensor 300and/or for enabling communication of sensor 300 with a remote device,such as processor 110 of FIG. 1.

Reference is now made to FIG. 4, which is a sectional view of anembodiment of receptacle 302 of toilet-bowl mounted sensor 300 in astand-by mode.

As seen, receptacle 302 has a wire frame bottom surface 320 as describedhereinabove, and side walls 322 surrounding a hollow 324. At least oneside wall, indicated in FIG. 4 by reference numeral 322 a includes aplurality of water jets 326 which receive water from conduit 310 and areadapted to spray water into hollow 324, in order to wash out excrementtherefrom.

A pushing mechanism 330, which in some embodiments includes a pluralityof wire frame elements 332 (seen clearly in FIG. 5A) connected to oneanother by a connector surface 334 (seen clearly in FIG. 5A), isdisposed within receptacle 302 and is movable relative to one of sidewalls 322 b, as explained in further detail hereinbelow. Pushingmechanism 330 is adapted to move back-and-forth along the receptacle 302between side walls 322 b and 322 c, so as to provide mechanical force onexcrement in the receptacle for breaking thereof into pieces that can beflushed out of the receptacle via the wire frame bottom 320. In someembodiments, pushing mechanism 330 is further adapted to sense theBristol stool measure of the excrement in receptacle 302, for example bysensing the three exerted by the motor driving the pushing mechanism 330for breaking down the excrement.

A side of pushing mechanism distal to the side wall 322 b includes adiagonal section 336 terminating in a generally hemispherical ingress338, which, together with a corresponding diagonal section 340 andgenerally hemispherical ingress 342 formed in an opposing side wall 322c of receptacle 302 are adapted for capturing a vibrating ingestiblecapsule and for measurement and identification thereof, as described infurther detail hereinbelow.

Disposed beneath ingress 342 is a capsule releasing mechanism 344,adapted, following capturing of an expelled capsule and identificationthereof, to release the capsule from receptacle 302 for flushing thereofdown the toilet. In some embodiments, releasing mechanism 344 comprisesa hatch 346 (seen clearly in FIG. 7), hingedly connected to side wall322 c, which is adapted to open and release a captured capsule followingidentification thereof, and to close back immediately following removalof the capsule.

It will be appreciated that though in the illustrated embodiment thebottom surface 320 is slanted toward side wall 322 e and ingress 342, soas to allow gravity to assist a capsule in arriving at its capturinglocation as described in further detail hereinbelow, in some embodimentsthe bottom surface 320 may be horizontal and perpendicular to the sidewalls 322 b and 322 c.

Included within side wall 322 c, adjacent to ingress 342, is a capsuleidentification mechanism 350, which may include one or more sensors 352,a vision system 354, a communication system, and/or a weighingmechanism, for measuring the dimensions and/or weight of a capturedcapsule, and/or for uniquely identifying the capsule.

As described in further detail hereinbelow, sensors 352 may be contactsensors or distance sensors adapted to sense contact between, or adistance between, diagonal sections 336 and 340 and/or contact between acapsule captured between ingresses 338 and 342 and the ingress walls.

Vision system 354 has a field of view, and is typically adapted to viewa wall of a captured capsule via the field of view, so as to uniquelyidentify the capsule. In some embodiments, the vision system may includea barcode reader adapted to identify a barcode printed onto the exteriorof a captured capsule, a QR-code reader adapted to identify a QR-codeprinted onto the exterior of a captured capsule, an OCR mechanismadapted to scan and interpret text or an identification number printedonto the exterior of a captured capsule, or an image capturing andanalysis mechanism adapted to capture an image of the exterior of thecapsule and to analyze the captured image thereby to identify thecapsule or a manufacturer thereof.

In some embodiments, the communication system includes an RFID tagreader adapted to read an RFID tag mounted on the exterior of a capturedcapsule, thereby to identify capsule. The communication system may beincorporated in the vision system or may be separate therefrom.

The weighing mechanism may be disposed on bottom surface 320 of thereceptacle 302, preferably adjacent to ingress 342, so as to weigh acapsule captured between ingresses 338 and 342, as described in furtherdetail hereinbelow. In some embodiments, weighing mechanism is mountedonto releasing mechanism 344.

Controller 308 of receptacle 302 may be disposed on or within one ormore of side walls 322 and is adapted to control movement, and in someembodiments sensing capabilities, of pushing mechanism 330, and tocontrol operation of identification mechanism 350 and of releasingmechanism 344. Additionally, controller 308 is adapted to provide powerto pushing mechanism 330, releasing mechanism 344 and identificationmechanism 350.

In some embodiments, controller 308 is adapted to receive input fromweighing mechanism 344 and/or from identification mechanism 350, so asto identify that a capsule has been captured, and the dimensions,weight, and/or identity of the captured capsule. In some embodiments,controller 308 includes a clock for identifying a time at which acapsule was captured and/or identified.

Typically, controller 308 is adapted to communicate with a remotelocation, such as processor 110, via a communication module forming partof the controller and/or via a communication wire 310 extending fromreceptacle 302, along toilet bowl 306 to the remote location. In someembodiments, the controller 308 may communicate the time at which thecapsule was captured, and information regarding the capsule, such as itsdimensions, weight, and/or identity, to the remote location, for usethereof. For example, in the embodiment of FIGS. 1 and 2, theinformation provided by the controller 308 may be used to identify atime that the capsule has spent in the GI tract of the subject, or anorder at which a plurality of ingested capsules were expelled.

In some embodiments, the controller 308 may further communicateinformation relating to characteristics of the expelled fecal matter,such as a Bristol stool measure thereof, as sensed by pushing mechanism330 or by the motor driving the pushing mechanism. In some suchembodiments, the controller 308 only communicates the informationrelating to the fecal matter if a capsule was captured, or if a capsuleof a specific type was captured.

In the embodiment illustrated in FIG. 4, controller 308 has a firstportion 308 a disposed within side wall 322 b and adapted to control andto provide power to pushing mechanism 330, and a second portion 308 bdisposed within side wall 322 c and adapted to control and to providepower to releasing mechanism 344 and identification mechanism 350.However, any other arrangement of controller 308 is considered withinthe scope of the invention.

Reference is now made to FIGS. 5A and 5B, which are, respectively, aperspective view and a sectional view of the receptacle 302, in anoperational mode. As seen, pushing mechanism 330 is being pushed awayfrom side wall 322 b and toward side wall 322 c, as indicated by arrow370. A vibrating ingestible capsule 372, which was expelled from thebody of a subject together with fecal matter thereof, is caught byreceptacle 302, and may be pushed by pushing mechanism 330 towardingress 342 and identification mechanism 350. In some embodiments,capsule 372 is generally ovoid, is symmetrical about a longitudinal axis374, and has a generally circular cross-section in a directionperpendicular to axis 374.

It will be appreciated that pushing mechanism 330 may be pushed in thedirection of arrow 370 and back in the opposite direction multipletimes, so as to break down fecal matter caught in receptacle 302 forremoval thereof via bottom surface 320. In some embodiments, motion ofpushing mechanism 330 is accompanied by water spray from jets 326 forwashing away fecal matter and cleaning of the capsule, prior to pushingand/or capturing thereof.

Reference is now made to FIG. 6, which is a partial sectional view ofreceptacle 302 in a capsule capturing mode. As seen in FIG. 6, pushingmechanism 330 is pushed distally from side wall 322 b until it engagesside wall 322 c, such that diagonal sections 336 and 340 engage oneanother, and such that the capsule 372 is trapped between ingresses 338and 342. It is a particular feature of the present invention that thearrangement of the wire frame of bottom surface 320, and ingress 338 ofpushing mechanism 330, cause capsule 372 to be captured such thatlongitudinal axis 374 is generally parallel to side wall 322 c, and suchthat the circular cross section of the capsule substantially fills thecircular cross-section formed by ingresses 338 and 342.

It is a particular feature of the teachings herein that capturing of thecapsule, results in measurement of its dimensions. Specifically, sensors352 of the identification mechanism 350 identify the dimensions of thecapsule. Sensors 352 a mounted along section 340 identify whether or notdiagonal sections 336 and 340 engage one another—if the diagonalsections do not engage one another when the capsule is captured, thecapsule has a greater circumference than that of the circular crosssection of the cavity between ingresses 338 and 342. Sensors 352 bmounted along ingress 342 identify whether or not the circumference ofthe capsule engages the ingress wall—if the circumference of the capsuledoes not engage the ingress walls when the capsule is captured, thecapsule has a smaller circumference than that of the circular crosssection of the cavity between ingresses 338 and 342. In someembodiments, weighing mechanism 358, which may be disposed beneathingresses 338 and 342, identifies the weight of capsule 372 while thecapsule is captured.

In some embodiments, the circular cross-section of the cavity betweeningresses 338 and 342 may be specifically sized to match the crosssection of a particular type of capsule, such that controller 308 mayidentify, based on input received from sensors 352, whether or not thecaptured capsule is of the particular type. Additionally, even if thedimensions of captured capsule 372 match the expected dimensions,controller 308 may use the identified weight of the capsule to determinewhether the capsule is indeed of the expected particular type. Thecontroller 308 may report capture of the capsule, for example toprocessor 110, if the capsule has the expected dimensions and weight,and may choose not to report capture of the capsule if it is differentlysized or has a different weight.

When the capsule 372 is captured between ingresses 338 and 342, visionsystem 354 may view a portion of the exterior of the capsule 372 viafield of view 355, and may thus uniquely identify the capsule. Asdescribed above, in one example, the capsule may have a barcode printedthereon, and the vision system includes a barcode reader adapted toidentify the capsule by reading the barcode printed thereon. In anotherexample, the capsule may have a QR-code printed thereon, and the visionssystem includes a QR-code reader adapted to identify the capsule byreading the code printed thereon. In yet another example, the capsulehas a specific logo and/or an identification or serial number printed onthe exterior thereof, and vision system 354 includes an OCR mechanism orother mechanism suitable for reading the logo and serial number, therebyto identify the capsule.

In some embodiments, identification of the capsule may alternately oradditionally be accomplished by communication system 356. For example,the communication system may include an RFID tag reader, which mayidentify an RFID tag mounted on the exterior of the captured capsule.Following identification of the capsule, the controller 308 may reportcapturing of the capsule, and information about the capsule, to a remotelocation, as described hereinabove. In some embodiments, the controller308 may report the information only if the capsule is identified asbelonging to a specific manufacturer, or as being of a specific type,for example as described hereinabove.

Reference is now made to FIG. 7, which is a sectional view of receptacle302 in a capsule releasing mode. As seen in FIG. 7, following completionof the capsule identification, pushing mechanism 330 may be displacedaway from side wall 322 c so as to release the capsule 372 from thehollow between ingresses 338 and 342, and hatch 346 of releasingmechanism 344 may open, for example by rotating downwardly relative tobottom surface 320, so as to allow the capsule 372 to drop out ofreceptacle 302 b, and to be flushed down the toilet. In someembodiments, the releasing mechanism is electrically controlled bycontroller 308, such that hatch 346 recloses after a predeterminedduration during which it is assumed that the capsule has been removedfrom the receptacle, or after sensors, for example on hatch 346,identify releasing of the capsule.

Reference is now additionally made to FIG. 8, which is a schematicflowchart of a method for capturing and identifying an ingestiblecapsule that has been expelled into a toilet bowl according to thepresent invention, the method utilizing the inventive toilet-bowlmounted sensor 300 of any one of FIGS. 3A-7.

At an initial step 400, excrement including an ingestible capsule iscaptured in a receptacle, such as receptacle 302, of the sensor 300. Thepushing mechanism 330 is pushed forward (toward side wall 322 c) andback (away from side wall 322 c and toward side wall 322 b), so as toapply mechanical force to the excrement for breaking down thereof, asseen at step 402.

Subsequently or simultaneously to the breaking action of the pushingmechanism, at step 404, water jets 326 are activated to wash awayexcrement, which may be removed from the receptacle via the wire frameof bottom surface 320.

In some embodiments, steps 402 and 404 may be repeated for apredetermined number of cycles, a predetermined duration, or untilcontroller 308 determines that there is little or no residual excrementremaining on the capsule or in the receptacle.

At step 406, following removal of excrement and cleaning of the capsule,the pushing mechanism 330 is displaced toward side wall 322 c, pushingthe capsule in that direction, until the pushing mechanism 330 can moveno further.

At step 408, controller 308 assesses whether or not the pushingmechanism has engaged the side wall of the receptacle, and morespecifically, whether or not diagonal sections 336 and 340 engage oneanother, for example using sensors 352 a (FIG. 7).

If the pushing mechanism can move no further, but diagonal sections 336and 340 do not engage one another, this is indicative of the capturedcapsule having a greater cross-section circumference than the expectedcapsule, and at step 410 the controller concludes that the capturedcapsule is not of the expected type. At step 412, the releasingmechanism is operated to release the captured capsule, for example byopening hatch 346 as described hereinabove.

Otherwise, if at step 408 it is determined that the diagonal sections336 and 340 engage one another, at step 414 controller 308 assesseswhether the exterior surface of the captured capsule engages the surfaceof the cavity between ingresses 338 and 342, for example by using sensor352 b (FIG. 7).

If the capsule does not engage the surface of the cavity when diagonalsections 336 and 340 engage one another, this is indicative of thecaptured capsule having a smaller cross-section circumference than theexpected capsule, and the method continues to step 410 where thecontroller concludes that the captured capsule is not of the expectedtype and to step 412 where the capsule is released from the receptacle.

If the capsule is determined to have the expected dimensions, controller308 may receive from the weighing mechanism information relating to aweight of the captured capsule, and may determine, at step 418, whetheror not the measured weight of the capsule matches, or is within apredetermined margin of error, of an expected weight of the capsule. Ifthe measured weight of the capsule does not match the expected weight,the method continues to step 410 where the controller concludes that thecaptured capsule is not of the expected type and to step 412 where thecapsule is released from the receptacle.

Otherwise, the controller concludes that the capsule is of the expectedtype, and at step 422 the identification mechanism uniquely identifiesthe capsule, for example by reading a barcode, QR code, uniqueidentification number or string of characters, or an RFID tag located onthe exterior surface of the capsule.

At step 424 the controller may report to a remote location, such asprocessor 110 of FIG. 1, information relating to the capsule, such asthe time the capsule was expelled from the body of the user or the timethat the capsule was identified by the identification mechanism, and/orthe unique identification of the capsule, which information may be usedto better understand the subject's response to treatment with thecapsule. In some embodiments, the controller may further reportinformation regarding the fecal matter, such as a Bristol stool measurethereof, as identified by the pushing mechanism and as describedhereinabove. As discussed in detail hereinabove, the reporting may becarried out by wired or wireless communication between the controller308, or another portion of the sensor 300, and the remote location.

Subsequently or in parallel to such reporting, the capsule is releasedfrom the receptacle, at step 412.

It will be appreciated that certain features of the invention, whichare, for clarity, described in the context of separate embodiments, mayalso be provided in combination in a single embodiment. Conversely,various features of the invention, which are, for brevity, described inthe context of a single embodiment, may also be provided separately orin any suitable sub-combination.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims. All publications, patents and patentapplications mentioned in this specification are herein incorporated intheir entirety by reference into the specification, to the same extentas if each individual publication, patent or patent application wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis application shall not be construed as an admission that suchreference is available as prior art to the present invention.

1. A system for treatment of a disorder in a gastrointestinal (GI) tractof a subject, the system comprising: a programmable vibrating ingestiblecapsule adapted to be programmed and activated to implement a vibrationprotocol defined in a treatment protocol, and adapted, in an operativemode, to deliver vibrations to a wall of the GI tract of the subject inaccordance with said vibration protocol, thereby to treat the subject; adatabase including data relating to subjects treated for disorders inthe gastrointestinal tract and to treatment protocols used for saidsubjects; a capsule control unit including: at least one input moduleadapted to receive input from at least one of the subject, a medicalpractitioner treating the subject, and a care giver of the subject; acomputer readable memory storing a subject profile for the subject, saidsubject profile including subject data, at least part of said subjectdata received as input by said at least one input module; acommunication module for remotely transmitting data to said programmablevibrating ingestible capsule; and a processor, functionally associatedwith said at least one input module, said communication module, saidcomputer readable memory, and said database, wherein said at least oneinput module is adapted to receive feedback regarding a response of thesubject to treatment in accordance with said treatment protocol, andwherein said processor is configured, based at least one said feedback,to automatically obtain an updated recommendation for an updatedrecommended treatment protocol based on at least one of said feedback,said subject data included in said subject profile, and said dataincluded in said database, said data relating to at least one othersubject of said subjects.
 2. The system of claim 1, wherein saidprocessor is further configured to effect programming of saidprogrammable vibrating ingestible capsule to implement said vibrationprotocol.
 3. The system of claim 2, wherein said processor is furtherconfigured, prior to effecting programming of said programmablevibrating ingestible capsule, to: obtain an initial recommendation foran initial recommended treatment protocol based on at least onecharacteristic included in said subject data; and generate saidtreatment protocol based on said initial recommended treatment protocol.4. The system of claim 1, wherein said processor is further configuredto: provide said updated recommended treatment protocol to a decisionmaker; receive from said decision maker an indication whether or notanother treatment protocol should be identical to said updatedrecommended treatment protocol; and if said indication indicates thatmodifications are required to said updated recommended treatmentprotocol, modify said updated recommended treatment protocol inaccordance with said required modifications to generate said anothertreatment protocol.
 5. The system of claim 1, further comprising asecond programmable vibrating ingestible capsule adapted to beprogrammed and activated to implement another vibration protocol definedin another treatment protocol, and adapted, in an operative mode, todeliver vibrations to a wall of the GI tract of the subject inaccordance with said another vibration protocol, thereby to treat thesubject, and wherein said capsule control unit is adapted to receivefrom said processor said another vibration protocol and to program saidsecond programmable vibrating ingestible capsule to implement saidanother vibration protocol.
 6. The system of claim 1, wherein saidfeedback comprises at least one of: feedback received from the subjectindicating times at which the subject experienced bowel movements duringor following said treatment in accordance with said treatment protocol;feedback received from the subject indicating a physical feelingexperienced by the subject during or following said treatment inaccordance with said treatment protocol; and feedback received from thesubject indicating at least one characteristic of fecal matter excretedby the subject during or following said treatment in accordance withsaid treatment protocol.
 7. The system of claim 1, further comprising atleast one sensor adapted to provide to said processor informationregarding expelling of said programmable vibrating ingestible capsulefrom the body of the subject.
 8. The system of claim 7, wherein saidinformation regarding expelling includes at least one of: a time atwhich said programmable vibrating ingestible capsule was expelled fromthe body of the subject; an identification of said programmablevibrating ingestible capsule; and information regarding at least onecharacteristic of excrement excreted from the body of the subject. 9.The system of claim 7, wherein said at least one sensor comprises atoilet-bowl mounted sensor.
 10. The system of claim 1, wherein saidprocessor is further configured to use said subject data and saidreceived feedback to update said database to reflect said response ofthe subject to said treatment in accordance with said treatmentprotocol.
 11. A method for treatment of a disorder in a gastrointestinaltract of a human subject, the method including: (a) using a capsulecontrol unit, programming a programmable vibrating ingestible capsule toimplement a vibration protocol defined in a treatment protocol; (b)activating said programmable vibrating ingestible capsule to carry outsaid vibration protocol, said vibration protocol including deliveringvibrations to a wall of the GI tract of the subject, thereby to treatthe subject; (c) receiving feedback regarding a response of the subjectto treatment in accordance with said treatment protocol; and (d)automatically and electronically obtaining, at said capsule controlunit, an updated recommendation for an updated recommended treatmentprotocol based on at least one of said feedback, subject data stored ina subject profile relating to the human subject, and data included in adatabase, said data relating to at least one other subject.
 12. Themethod of claim 11, further comprising, following (d): (e) programming asecond programmable vibrating ingestible capsule to implement anothervibration protocol defined in another treatment protocol, said anothertreatment protocol being based on said updated recommended treatmentprotocol; and (f) activating said second programmable vibratingingestible capsule to carry out said another vibration protocol, saidanother vibration protocol including delivering vibrations to a wall ofthe GI tract of the subject, thereby to treat the subject.
 13. Themethod of claim 11, further comprising, prior to (a): (g) receiving fromthe subject initial input including said subject data; (h) obtaining aninitial recommendation for an initial recommended treatment protocolbased on at least one characteristic included in said subject data; (i)generating said treatment protocol based on said initial recommendedtreatment protocol.
 14. The method of claim 11, wherein said receivingfeedback includes receiving from the subject at least one of: feedbackindicating times at which the subject experienced bowel movements duringor following said treatment in accordance with said treatment protocol;feedback indicating a physical feeling experienced by the subject duringor following said treatment in accordance with said treatment protocol;and feedback indicating at least one characteristic of fecal matterexcreted by the subject during or following said treatment in accordancewith said treatment protocol.
 15. The method of claim 11, wherein saidreceiving feedback includes receiving, from at least one sensor,information regarding expelling of said programmable vibratingingestible capsule from the body of the subject.
 16. The method of claim15, wherein said information regarding expelling includes at least oneof: a time at which said programmable vibrating ingestible capsule wasexpelled from the body of the subject; an identification of saidprogrammable vibrating ingestible capsule; and information regarding atleast one characteristic of fecal matter excreted from the body of thesubject.
 17. The method of claim 15, wherein said at least one sensorincludes a toilet-bowl mounted sensor, and wherein said receiving saidinformation from said at least one sensor comprises: at said toilet-bowlmounted sensor, identifying at least one of said programmable vibratingingestible capsule and fecal matter being expelled from the body of thesubject; at said toilet bowl sensor, gathering said informationregarding expelling of said programmable vibrating ingestible capsule orof expelled fecal matter; and transmitting said information from saidtoilet-bowl mounted sensor.
 18. The method of claim 12, furtherincluding, following (d) and prior to (e): providing said updatedrecommended treatment protocol to a decision maker; receiving from saiddecision maker an indication whether or not said another treatmentprotocol should be identical to said updated recommended treatmentprotocol; when said indication obtained from said decision makerindicates that said another treatment protocol should be identical tosaid updated recommended treatment protocol, using said updatedrecommended treatment protocol as said another treatment protocol; andwhen said indication obtained from said decision maker indicates thatsaid another treatment protocol should not be identical to said updatedrecommended treatment protocol: obtaining from said decision maker atleast one change to be made to said updated recommended treatmentprotocol; and applying said at least one change to said updatedrecommended treatment protocol, thereby to obtain said another treatmentprotocol.
 19. The method of claim 12, wherein said programming saidsecond programmable vibrating ingestible capsule includes: providingsaid another vibration protocol to said capsule control unit; and saidcapsule control unit programming said second programmable vibratingingestible capsule to implement said another vibration protocol.
 20. Themethod of claim 11, further including, following (c), using saidreceived feedback together with said subject data to update saiddatabase to reflect said response of the subject to said treatment inaccordance with said treatment protocol.